Composite oral appliances and methods for manufacture

ABSTRACT

Oral appliances adapted to for spacing the occlusal surfaces of the teeth of a user are disclosed. The oral appliances have an integral retention band interconnecting a first bite pad and a second bite pad. The first bite pad can include a first spacer and the second bite pad can include a second spacer that are configured to maintain the spacing of the occlusal surfaces of opposing teeth of a user during clenching or upon an impact to the jaw. Methods for the manufacture of composite oral appliances are also disclosed. The methods include forming a composite oral appliance over a model of a user&#39;s mouth.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 10/460, 886, filed on Jun. 12, 2003 and nowpublished as U.S. Pat. Pub. No. 2004/0250817, now U.S. Pat. No.8,074,658 which is a continuation-in-part of U.S. patent applicationSer. No. 09/657,421, filed on Sep. 8, 2000 and now issued as U.S. Pat.No. 6,626,180 each of which is hereby incorporated by reference into thepresent disclosure. The present application is also a continuation ofInternational Patent application No. PCT/US2009/047295, filed on Jun.14, 2009, which claims the benefit and priority of U.S. ProvisionalPatent Application No. 61,132,588, filed on Jun. 19, 2008, both of whichare incorporated by reference into the present disclosure.

BACKGROUND OF THE INVENTION

1. Summary of the Invention

The present inventions relate to mouthpieces and, more particularly, tooral devices for spacing the occlusal surfaces of the teeth of a user.

2. Description of the Related Art

Stress is a normal physiologic response and can be beneficial,maintaining alertness, focus, and efficiency. However, the body canbecome overloaded when stress becomes excessive (such as during the“fight or flight response”) and both performance and health may beadversely affected. Teeth clench in response to elevated stress levels.This clenching mechanism may complete a circuit, as it were, and maysignal the brain to begin a complex series of responses in thehypothalamic-pituitary-adrenal (HPA) axis. The HPA axis is a feedbackloop signaling the release of hormones and affects various parts of thebody. When someone is faced with a stressful situation, the hypothalamusreleases the corticotropin-releasing hormone (CRH), which activates thepituitary gland to release adrenocorticotropin into the bloodstream.This triggers the adrenal glands to release epinephrine (adrenaline),norepinephrine (noradrenaline), and cortisol, all enabling the body'sstress response. Epinephrine increases blood pressure, reaction time,and heart rate, and sends blood to the muscles. Cortisol releasesglucose to supply the brain and muscles with immediate energy. The HPAaxis communicates with regions of the brain, including the limbicsystem, which controls motivation and mood. It also communicates withthe hippocampus, which has a vital role in memory formation, mood, andmotivation. Other affected areas include body temperature, appetite, andpain control. Stress will also shut down hormonal systems, which affectsgrowth, metabolism, and immunity. This serves as a useful short-termsolution when the body must marshal its energies to confront or run fromthe source of stress. However, stress's interference outlives itsusefulness and becomes detrimental when chronic.

Cortisol, the “stress hormone,” is essentially the trigger foradrenaline. Cortisol belongs to a class of hormones calledglucocorticoids, which affect almost every organ and tissue in the body.Scientists believe cortisol has hundreds of positive effects in the bodybut Cortisol's most important role may be to help the body respondproperly to stress. Cortisol helps maintain blood pressure andcardiovascular function and is essential to normal functioning but needsto remain in proper balance. At excessively high levels, particularlyfor long periods, the whole endocrine system is affected negatively.High cortisol levels limit peripheral vision, decrease metabolism, causefatigue, reduce muscle-building, and suppress the immune system. Theresults of tests showing, among other benefits, a significant increasein endurance as well as a marked reduction in Cortisol during stress.Therefore, a need exists for an apparatus that can interrupt thefight-or-flight signal by preventing the completion of the clenchingmechanism.

Similar to other forms of stress, the natural inclination to clench thejaw during physical exertion is typically difficult to avoid. There arevarious theories as to why individuals clench their teeth in a widevariety of circumstances. One theory is that this is a primal reflexdesigned to protect the jaw from displacement or fracture. People stillinstinctively clench their teeth during aggression or physical activity.Accordingly, a need exists for an apparatus that may inhibit or preventthis clenching from completing “the circuit” that could signal the brainto begin a complex series of responses in thehypothalamic-pituitary-adrenal (HPA) axis.

It is also well recognized that the birthing process creates atremendous amount of physiological and psychological stress upon themother. The actual birthing process is very analogous to athletes aswomen about to give birth may very well clench their teeth during theexertion of labor. Therefore, a need exists for an apparatus that caninterrupt the resulting physiological response by preventing thecompletion of the clenching mechanism.

It is also well recognized that military service generates a tremendousamount of physiological and psychological stress in the soldiers. Thisstress may result in regular clenching of the soldiers' teeth as theyduring the exertion of labor. This clenching can cause a number ofchanges that can detrimentally affect their physiology, psychology andjudgment. Therefore, a need exists for an apparatus that preventing thecompletion of the clenching mechanism.

To be useful, an apparatus that prevents the completion of the clenchingmechanism should be comfortable and unobtrusive and should not impedebreathing or speaking to promote its use. However, many current designsfor devices worn in the mouth have significant visual clues that theyare being worn. They also frequently impede speech causing many users tohave a lisp when they speak. Further, certain designs can significantlyimpede breathing through the mouth. Therefore, a need exists forapparatus that is both comfortable and unobtrusive when worn by a user.

For adequate fit and comfort, custom manufacture of certain oralappliance designs based on models of the users' teeth can be necessary.However, custom manufacture can be laborious and expensive. Therefore, aneed exists for simple reproducible methods for manufacturing oralappliances that reduce the time and effort involved in the manufactureof custom oral appliances.

SUMMARY OF THE INVENTION

Apparatus and methods in accordance with the present invention mayresolve many of the needs and shortcomings discussed above and willprovide additional improvements and advantages as will be recognized bythose skilled in the art upon review of the present disclosure.

In certain aspects, a composite oral appliance in accordance with thepresent invention may include: a body defining at least a first teethfitment portion and a second teeth fitment portion including an integralretention band securing the first teeth fitment portion to the secondteeth fitment portion with each of the first teeth fitment portion andthe second teeth fitment portion configured to be secured over at leastsome teeth of a user and with each of the first teeth fitment portionand the second teeth fitment portion having a composite structure, thecomposite structure comprising at least an outer layer secured over aninner layer, the first teeth fitment portion further defining at least afirst bite pad and the second teeth fitment portion defining at least asecond bite pad, the composite structure at each of the first bite padand the second bite pad comprising at least a spacer secured between anouter layer and an inner layer, the first bite pad and the second bitepad in positions to contact at least one of a molar and a premolar whenworn by the user, an inner surface of the inner layer defining the shapeof the teeth of a user.

In certain aspects, a method for manufacturing a composite oralappliance in accordance with the present invention may include:providing a model of one of an upper set of teeth and a lower set ofteeth; forming an inner blank over at least a portion of the model;positioning a first spacer and a second spacer on an upper surface ofthe inner blank over at least one of a molar and a premolar of themodel; forming an outer blank over at least a portion of the model; andsecuring the outer blank over the inner blank to form at least a firstbite pad securing at least the first spacer and a second bite padsecuring at least a second spacer to relatively secure at least aportion of the outer blank, the first spacer, the second spacer, and theinner blank together as a composite structure.

In certain aspects, a method for manufacturing a composite oralappliance in accordance with the present invention may further include:forming the inner blank, comprising: positioning the model in a formingchamber of a pressure forming apparatus; sealingly engaging an innerblank between the forming chamber and a high pressure chamber of thepressure forming apparatus; and generating a pressure differentialbetween the forming chamber and the high pressure chamber to draw aportion of the blank over the model.

In certain aspects, a method for manufacturing a composite oralappliance in accordance with the present invention may further include:forming the outer blank, comprising: sealingly engaging an outer blankbetween the forming chamber and a high pressure chamber of the pressureforming apparatus; and generating a pressure differential between theforming chamber and the high pressure chamber to draw a portion of theblank over the first spacer and the second spacer and the first blank.

In certain aspects, a method for manufacturing a composite oralappliance in accordance with the present invention may further include:forming the outer blank, comprising: sealingly engaging an outer blankbetween the forming chamber and a high pressure chamber of the pressureforming apparatus; and generating a pressure differential between theforming chamber and the high pressure chamber to draw a portion of theblank over the first spacer and the second spacer and the first blank.

In certain aspects, a method for manufacturing a composite oralappliance in accordance with the present invention may further include:the step of forming a first tooth retention portion including the firstspacer and a second tooth retention portion including the second spacer,and the first teeth fitment portion secured to the second teeth fitmentportion by an integral retention band from the composite structure.

In certain aspects, a method for manufacturing a composite oralappliance in accordance with the present invention may further include:forming a first tooth retention portion including the first spacer and asecond tooth retention portion including the second spacer from thecomposite structure; and securing with the first teeth fitment portionsecured to the second teeth fitment portion with an integral retentionband.

In certain aspects, a method for manufacturing a composite oralappliance in accordance with the present invention may include:providing a model of one of an upper set of teeth and a lower set ofteeth; providing an inner material over the surface of at least one of amolar and a premolar of the model; positioning a first spacer and asecond spacer on an upper surface of the inner material over at leastone of a molar and a premolar on both a left side and a right side ofthe model; and forming an outer blank over at least a portion of thefirst spacer, the second spacer, the inner material and the model torelatively secure at least a portion of the outer blank, the firstspacer, the second spacer, and the inner material together as acomposite structure.

In certain aspects, a method for manufacturing a composite oralappliance in accordance with the present invention may further include:forming the outer blank, comprising: positioning the model in a formingchamber of a pressure forming apparatus; sealingly engaging a firstblank between the forming chamber and a high pressure chamber of thepressure forming apparatus; and generating a pressure differentialbetween the forming chamber and the high pressure chamber to form atleast a portion of the first blank over the first spacer and the secondspacer and the inner material.

In certain aspects, a method for manufacturing a composite oralappliance in accordance with the present invention may further include:forming a first tooth retention portion including the first spacer and asecond tooth retention portion including the second spacer, and thefirst teeth fitment portion secured to the second teeth fitment portionby an integral retention band from the composite structure.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates a perspective view of an exemplary embodiment of acomposite oral appliance generally configured to be positioned on thelower teeth of a user in accordance with aspects of the presentinventions;

FIG. 2 illustrates a perspective view of an exemplary embodiment of acomposite oral appliance generally configured to be positioned on theupper teeth of a user in accordance with aspects of the presentinventions;

FIG. 3A illustrates a perspective view of an exemplary embodiment of acomposite oral appliance generally configured to be positioned on theupper teeth of a user having a lingual strap in accordance with aspectsof the present inventions;

FIG. 3B illustrates a bottom view of an exemplary embodiment of acomposite oral appliance generally configured to be positioned on theupper teeth of a user having a lingual strap in similar to the applianceillustrated in FIG. 3A;

FIG. 3C illustrates a rear view of an exemplary embodiment of acomposite oral appliance generally configured to be positioned on theupper teeth of a user having a lingual strap in similar to the applianceillustrated in FIG. 3A;

FIG. 4A illustrates a perspective view of an exemplary embodiment of acomposite oral appliance generally configured to be positioned on thelower teeth of a user having a labial strap in accordance with aspectsof the present inventions;

FIG. 4B illustrates a top view of an exemplary embodiment of a compositeoral appliance generally configured to be positioned on the lower teethof a user having a labial strap in similar to the appliance illustratedin FIG. 4A;

FIG. 4C illustrates a rear view of an exemplary embodiment of acomposite oral appliance generally configured to be positioned on thelower teeth of a user having a labial strap in similar to the applianceillustrated in FIG. 4A;

FIG. 5A illustrates a side view of an exemplary embodiment of acomposite oral appliance positioned on the upper teeth of a user inaccordance with aspects of the present inventions;

FIG. 5B illustrates a cross section through section 5B-5B of thecomposite oral appliance of FIG. 5A illustrating the compositestructure;

FIG. 5C illustrates an exploded perspective view exemplary embodimentsof the components of the composite oral appliance as the components areassembled during manufacture in accordance with aspects of the presentinventions;

FIG. 5D illustrates a cross section of an exemplary embodiment of asheet positioned to be formed over a model of an individual's dentitionin accordance with aspects of the present inventions;

FIG. 5E illustrates a cross section of an exemplary embodiment of asheet positioned being formed over a model of an individuals dentitionin accordance with aspects of the present inventions;

FIG. 6A illustrates a side view of an exemplary embodiment of acomposite oral appliance positioned on the upper teeth of a user inaccordance with aspects of the present inventions;

FIG. 6B illustrates a cross section through section 4B-4B of thecomposite oral appliance of FIG. 4A illustrating the compositestructure; and

FIG. 6C illustrates an exploded perspective view exemplary embodimentsof the components of the composite oral appliance as the components areassembled during manufacture in accordance with aspects of the presentinventions;

All Figures are illustrated for ease of explanation of the basicteachings of the present invention only; the extensions of the Figureswith respect to number, position, relationship and dimensions of theparts to form the embodiment will be explained or will be within theskill of the art after the following description has been read andunderstood. Further, the exact dimensions and dimensional proportions toconform to specific force, weight, strength, and similar requirementswill likewise be within the skill of the art after the followingdescription has been read and understood.

Where used in various Figures of the drawings, the same numeralsdesignate the same or similar parts. Furthermore, when the terms “top,”“bottom,” “right,” “left,” “forward,” rearward,” “front,” “rear,”“first,” “second,” “inside,” “outside,” “upper,” “lower,” “inferior,”“superior,” “anterior,” “posterior,” “proximal,” “distal,” “facial,”“buccal,” “oral,” “lingual,” “palatal,” “distal,” “mesial,” and similarpositional and/or relative terms are used, the terms should beunderstood to reference the structures shown in the drawings as theywill typically be utilized by one skilled in the art or otherwise aswould be recognized by one skilled in the art.

DETAILED DESCRIPTION OF THE INVENTION

The present inventions provide composite oral appliances 10 and methodsfor their manufacture. The figures generally illustrate embodiments oforal appliances 10 and methods for their manufacture in accordance withthe present inventions. The particular exemplary embodiments of thecomposite oral appliances 10 illustrated in the figures have been chosenfor ease of explanation and understanding of the various aspects of thepresent inventions. These illustrated embodiments are not meant to limitthe scope of coverage but instead to assist in understanding the contextof the language used in this specification and the appended claims.Accordingly, variations of composite oral appliances 10 includingclaimed aspects of the inventions different from the illustratedembodiments may be encompassed by the appended claims.

Various embodiments of oral appliances 10 in accordance with aspects ofthe present invention are illustrated throughout the figures forexemplary purposes. The illustrated oral appliances 10 include at leasta first bite pad 12 and a second bite pad 14 interconnected by anintegral connector band 20. The first bite pad 12 may be defined by,secured to, or integral with in the body 16. Similarly, the second bitepad 14 may be defined by, secured to, or integral with the body 16. Theretention band 20 is typically integrally formed with the body 16 to atleast interconnect the first bite pad 12 to the second bite pad 14. Thebody 16 may further define a first tooth fitment portion 116 and asecond tooth fitment portion 216 (collectively, “fitment portions 116,216”) configured to generally configured to secure and/or position thefirst bite pad 12 and the second bite pad 14 (collectively, “bite pads12, 14”), respectively, at the desired position relative to the occlusalsurface of the teeth. In certain aspects, the first tooth fitmentportion 116 and the second tooth fitment portion 216 may each form achannel 18 or at least a portion of a channel 18 to receive the teeth ofa user. The channel 18 may solely extend in the area adjacent to thefirst bite pad 12 and the second bite pad 14 or may extend from thefirst bite pad 12 and the second bite pad 14 and around at least aportion of the retention band 20.

The first bite pad 12 includes at least a first spacer 32 and the secondbite pad 14 includes at least a second spacer 34. The first bite pad 12and the second bite pad 14 include a first spacer 32 and a second spacer34, respectively, formed from a material selected to maintain theseparation of the occlusal surfaces of the teeth during clenching orupon impact to the jaw. The bite pads 12, 14 may be configured to spacethe occlusal surface of one or more premolars and molars when the teethof a user are clenched and may be generally configured to reduce oralleviate pressure at the temporomandibular joint when the user's teethare clenched. In certain aspects, the bite pads 12, 14 of the compositeoral appliance 10 may tend to direct the mandibular condyle downwardfrom the articular fossa in response an attempt by a user to clenchtheir teeth. In other aspects, the composite oral appliance 10 may tendto direct the mandibular condyle downward and forward from the articularfossa in response an attempt by a user to clench their teeth. The bitepads 12, 14 may also or alternatively be generally configured to protectthe teeth and/or temporomandibular joint of a user when the user issubject to a blow to the jaw, head or otherwise receives an impactingforce that may travel to or through the jaw.

FIGS. 1, 2, 3A, and 4A illustrate perspective views of exemplaryembodiments of a composite oral appliance 10 configured to be positionedover the teeth of a user in accordance with aspects of the presentinventions. As illustrated, the embodiment of composite oral appliance10 may be configured to be received over at least some of the upperteeth or lower teeth of a user.

As illustrated, the body 16 of the oral appliance 10 defines a firsttooth fitment portion 116, a second tooth fitment portion 216, a firstbite pad 12, a second bite pad 16 and an integral connector band 20. Theintegral connector band 20 is configured to secure the first toothfitment portion 116 to the second tooth fitment portion 216. Theintegral connector band 20 is shown configured to be positioned againstany of the lingual, the palatal, the labial or the buccal surface of thegums and/or teeth. The first tooth fitment portion 116 has at least afirst bite pad 12 defined as a thickened region of the body 16 andincludes a first spacer 32 to maintain a desired thickness of the firstbite pad 12 during clenching or upon an impact to the jaw. The secondtooth fitment portion 216 also has at least a second bite pad 14 forpositioning on the opposite side of the mouth that is defined as athickened region of the body 16 and includes a second spacer 34 tomaintain a desired thickness of the second bite pad 14 during clenchingor upon an impact to the jaw. The first bite pad 12 and the second bitepad 14 are generally configured to be positioned over at least one ofthe lower molars on each side of a user's jaw when worn by a user. Whenthe upper teeth and the lower teeth of a user are juxtaposed, the firstbite pad 12 and the second bite pad 14 may be positioned between atleast some of the upper molars and/or premolars and some of the lowermolars and/or premolars. In certain embodiments, the first bite pad 12and the second bite pad 14 may cover at least a portion of the secondpremolar and at least a portion of the first molar on each side of thejaw of a user.

The body 16 is generally formed as a thin layer of material. Thematerial may be substantially rigid to permit the channel 18 to engagethe teeth to mechanically secure the body 16 over at least a portion ofthe lower teeth of a user. Various portions of the body 16 may becomposed of one or more layers of materials. These materials can includeethyl-vinyl acetate (EVA); thermoplastic polyolefin, variousethylene-based plasterers; various hydrocarbon resins (which are may becombined with EVA, thermoplastic polyolefin, or various ethylene-basedelastomers), polycaprolactone (which may be combined with EVA),low-density polyethylene, high density poly-ethylene, polycarbonateand/or various polymers, laminates and other materials that will berecognized by those skilled in the art upon review of the presentdisclosure. In certain aspects, the composite material may be apre-laminated sheet including a layer of polycarbonate bound to a layerof polyester urethane which is available under the trade name Durasoft®from the Scheu Dental Co. located in Iserlohn, Germany. Typically, thesematerials are selected with a durometer (hardness) of between 70 A to 96A or between 55 D and 90 D.

The integral connector band 20 connects the first bite pad 12 to thesecond bite pad 14. In certain embodiments, the integral connector band20 may secure the first tooth fitment portion 116 to the second toothfitment portion 216. The integral connector band 20 is typicallyintegrally formed with the body 16 along with the first bite pad 12 andthe second bite pad 14. The integral connector band 20 is configured toextend as an arch around the lingual and/or palatal sides of at leastthe front teeth of a user. In an oral appliance 10 fitted for the lowerteeth, the lower edge of the integral connector band 20 may in variousconfigurations extend along, below or above the gum line of the userwhile the upper edge of the integral connector band 20 up to or belowthe incisal edge of the teeth. In an oral appliance 10 fitted for theupper teeth, the upper edge of the integral connector band 20 may invarious configurations extend along, below or above the gum line of theuser while the upper edge of the integral connector band 20 up to orabove the incisal edge of the teeth. In certain embodiments, theintegral connector band 20 may define a channel 18 to receive at least aportion of both the lingual/palatal and buccal/labial sides of a user'steeth and may thus wrap around and cover the incisal edge of the teeth.In certain aspects, this positioning of the integral connector band 20can reduce the perceived obtrusiveness of the band within the mouth andcan also reduce the impact on a user's speech.

The integral connector band 20 may take the form of a thin sheet ofmaterial having a thickness from between about 1.0 millimeter to about6.0 millimeters. The band will typically take the form of a ribbon ofmaterial that is the same as the material of the body 16. The side orsides of the integral connector band 20 to be positioned against theteeth of a user may define one or more recesses 22. The recesses 22 maybe shaped to receive the adjacent tooth. In certain aspects, this maypermit the band to more tightly conform to the teeth of a user; mayimprove the comfort of the oral appliance 10; and may further secure theintegral connector band 20 and oral appliance 10 within the mouth of auser. The integral connector band 20 will typically be formed fromvarious polymers, various laminates, various natural materials or othersynthetic materials as will be recognized by those skilled in the artupon review of the present disclosure and which will typicallycorrespond with the material(s) of body 16.

At least the portion of the body 16 defining the first bite pad 12 andthe second bite pad 14 has a composite structure. The compositestructure including at least an outer layer 28 and an inner layer 26 ofmaterial secured to one another. The composite structure may alsoinclude a spacer 32, 34. The spacer 32, 34 may be positioned between theouter layer 28 and the inner layer 26. The spacer 32, 34 is typicallyformed from a material having a greater hardness than the material ofthe body 16. The spacer 32, 34 is typically of sufficient hardness toresist substantial penetration by the teeth and deformation as the teethof a user are clenched. A material such as high density polyethylene orpolypropylene may be used as well as other materials that will berecognized by those skilled in the art upon review of the presentdisclosure. The spacer 32, 34 may have a constant thickness from thefront edge to the rear edge of the spacer 32, 34, it may be thicker atthe front edge and be tapered to a thinner rear edge, it may have athinner front edge and be tapered to a thicker rear edge, or it may beotherwise configured as will be recognized by those skilled in the artupon review of the present disclosure.

At least a portion of the inferior surface of the first tooth fitmentportion 116 and the second tooth fitment portion 216 may conform to theshape of the teeth of the user. In certain aspects, one or more recesses22 may be formed in the channel 18 of the tooth fitment portions 116,216 to conform to and receive one or more teeth. The recesses 22 canenhance the fit, comfort and retention of the oral appliance 10 in themouth of a user. At least a portion of a superior surface of the firsttooth fitment portion 116 and the second tooth fitment portion 216 mayalso be shaped to correspond to the shape of the teeth of a user. Incertain aspects, this shape may enhance the comfort and aesthetics ofthe oral appliance 10. The first tooth fitment portion 116 and thesecond tooth fitment portion 216 typically form channels 18 to receivethe teeth. The channels 18 are elongated and are generally orientedalong the mesial-distal axis. The at least a portion of a channel 18 mayextend over one or more of the canines, premolars and/or molars on eachside of the mouth. The channel 18 may be configured in shape of theteeth of the user. The channel 18 or the portion of a channel 18 may bedefined by the inferior surface of the first tooth fitment portion 116and second tooth fitment portion 216 to receive the teeth of the user. Achannel occlusal surface 24 contacts at least a portion of the occlusalsurface of the teeth. The channel occlusal surface 24 may be configuredto conform to a least a portion of the occlusal surface of the user'steeth and may be configured to conform to the surfaces of all of theteeth received in the channel 18. To conform, typically, cavities willbe formed in the channel occlusal surface 24 to correspond to at leastthe cusps of the occlusal surfaces. In certain aspects, this may moreevenly distribute the force from clenching or an impact over theocclusal surface of the teeth and, among other things, may also improveretention and fitment.

When the teeth are engaged in the channel 18 in an oral appliance 10configured to be secured over the lower teeth, a buccal body edge 144 ofthe first tooth fitment portion 116 and second tooth fitment portion 216may extend below the lower gum-line of the user or some or all of thebuccal body edge 144 may be configured to extend to a point above thelower gum-line of a user. When the teeth are engaged in the channel 18in an oral appliance 10 configured to be secured over the upper teeth ofa user, the buccal body edge 144 of the first tooth fitment portion 116and second tooth fitment portion 216 may extend above the upper gum-lineof the user or some or all of the buccal body edge 144 may be configuredto extend to a point below the upper gum-line of a user.

The first tooth fitment portion 116 and the second tooth fitment portion216 each form a mesial body edge 140. The mesial body edge 140 istypically configured to be positioned at or distal to the canines whenthe oral appliance is positioned in the mouth of a user. This can reducethe comfort of the device by eliminating coverage of the lingual side ofthe incisors that can cause irritation to the tongue of users.

The first tooth fitment portion 116 and the second tooth fitment portion216 also each form a distal body edge 142. The distal body edge 142 istypically configured to be positioned at or mesial to the second molaror, when present, the third molar when the oral appliance is positionedin the mouth of a user.

At least the portion of the first tooth fitment portion 116 and thesecond tooth fitment portion 216 may define the first bite pad 12 andthe second bite pad 14 (collectively “bite pads” 12, 14). The bite pads12, 14 of oral appliance 10 may be configured to at least reducepressure in the temporomandibular joint as the lower mandible isclenched. In certain aspects, the oral appliance 10 may tend to directthe mandibular condyle downward from the articular fossa in response anattempt by a user to clench their teeth. In other aspects, the oralappliance 10 may tend to direct the mandibular condyle downward andforward from the articular fossa in response an attempt by a user toclench their teeth.

The first bite pad 12 and the second bite pad 14 may be solely include afirst spacer 32 and a second spacer 34 (collectively “spacers 32, 34”),respectively. Alternatively, the bite pads 12, 14 may be formed as acomposite structure with each bite pad 12, 14 including one or morespacers 32, 34. When the bite pads 12, 14 are formed as a compositestructure, the spacers 32, 34 may be embedded or encapsulated within oneor more materials forming the bodies 116, 216. As such, the bite pads12, 14 may include one or more of an outer layer 26 and an inner layer26 of material secured over one or more spacers 32, 34. The spacers 32,34 may be positioned between the outer layer 26 and the inner layer 26.The spacers 32, 34 are typically formed from a material having a greaterhardness than the material of the outer layer 26 and inner layer 26. Thespacers 32, 34 are typically of sufficient hardness to resistsubstantial penetration by the teeth and deformation as the teeth of auser are clenched. A material such as high density polyethylene orpolypropylene may be used as well as other materials that will berecognized by those skilled in the art upon review of the presentdisclosure. The spacers 32, 34 may have a constant thickness from thefront edge to the rear edge of the spacers 32, 34, it may be thicker atthe front edge and be tapered to a thinner rear edge, it may have athinner front edge and be tapered to a thicker rear edge, or it may beotherwise configured as will be recognized by those skilled in the artupon review of the present disclosure.

The bite pads 12, 14 are generally configured to define an externalocclusal surface 22 to contact at least a portion of the occlusalsurface of the opposing teeth and a channel occlusal surface 24 tocontact the occlusal surfaces of the teeth relative to which the oralappliance 10 is secured. At least a portion of the channel occlusalsurface 24 is coextensive with the channel occlusal surface 24 and mayinclude the characteristics and features of the channel occlusal surface24 as described above. The bite pads 12, 14 are generally configured tobe positioned adjacent the occlusal surfaces of at least one of thecanines, the premolars and the molars with at least one bite pad 12, 14on each side of a user's mouth. Typically, the bite pads 12, 14 arepositioned over the occlusal surfaces of at least one the premolars andat least one of the molars. In other aspects, the bite pads 12, 14 maybe solely positioned over the occlusal surfaces of one or more molars.

In various aspects, the spacers 32, 34 of the bite pads 12, 14 may beconfigured to at least one of guide the mandible into a position thatreduces or alleviates pressure at the temporomandibular joint duringclenching and/or to transfer at least a portion of the force from animpact to the jaw to the cranium through the maxilla. The spacers 32, 34are typically formed from a material having a sufficient hardness toresist substantial deformation when the teeth of a user are clenchedwhile in contact with the spacer 32, 34. Accordingly, the spacers 32, 34typically will have a durometer of between about 60 D to about 90 Dalthough this may vary in certain embodiments of the invention.

Typically, the spacers 32, 34 are configured to be generally coextensivewith the bite pads 12, 14. From a top view, the spacers 32, 34 may havean oblong shape and can be generally rectangular shape, a kidney shape,an oval shape, an egg shape or be otherwise shaped to extend along atleast a portion of an occlusal surface of the underlying teeth as willbe recognized by those skilled in the art upon review of the presentdisclosure. The spacers 32, 34 may define a mesial edge 40, a distaledge 42, a buccal edge 44, a lingual edge 46, a spacer channel surface48, and a spacer outer surface 50. The spacers 32, 34 are generallyconfigured to space the occlusal surface of opposing teeth when aclenching force is exerted by the user. For purposes of the presentdescription, the length of the spacers 32, 34 extends between a mesialedge 40 and a distal edge 42 of the spacers 32, 34, the width of thespacers 32, 34 extends between a buccal edge 44 and a lingual edge 46 ofthe spacer, and the thickness of the spacers 32, 34 extends along thespacer channel surface 48 and an spacer channel surface 48 of thespacers 32, 34. Depending upon the particular application and particularproducts design, the length of the spacers 32, 34 is typically betweenabout 10 millimeters to about 25 millimeters. The width of the spacers32, 34 may be selected to contact or otherwise provide support betweenopposing teeth. The spacers 32, 34 are typically at least as wide as thedistance between the cusps of individual adjacent teeth and the cusps ofthe opposing teeth. In certain aspects, the width may be as wide orwider than the width of the adjacent teeth or at least as wide as thespacing of the cusps of the teeth. Typically, they will be between about5 millimeters and 15 millimeters. The thickness of the spacers 32, 34generally establishes the distance the teeth will remain separated whenthe jaw is clenched or upon impact. The thickness of the spacers 32, 34is typically between 0.25 millimeter and 2.5 millimeters. However, thespacers 32, 34 may have a constant thickness, a decreasing thicknessalong its length, or have their thickness otherwise varied along theirlength and/or width to reduces or alleviates pressure at thetemporomandibular joint during clenching and/or to transfer at least aportion of the force from an impact to the jaw to the cranium throughthe maxilla. In certain aspects, the spacers 32, 34 may be configured aswedges with a thickness at their mesial ends that may approach 0.00millimeters and a thickness at their distal ends between 0.25 millimeterand 2.5 millimeters. However, the mesial edge 40 of wedge shaped spacers32, 34 typically has a thickness of at least 0.20 millimeters and thethickness at their distal ends of between 0.50 millimeters and 2.00millimeters.

FIGS. 3A and 3C illustrate various features of an embodiment of an oralappliance 10 for positioning on upper teeth of a user. As illustrated,one or more molars and premolars may be positioned within the channel 18defined by each of the first tooth fitment portion 116 and the secondtooth fitment portion 216. The integral connector band 20 is configuredto extend around the front of the mouth along the palatal surface ofincisors and canines. The integral connector band 20 defines a pluralityof recesses 22 shaped to receive a palatal surface of the incisors andcanines of a user. The integral connector band 20 extends mesial fromlabial sides of the mesial body edges 140 of the first tooth fitmentportion 116 and the second tooth fitment portion 216. The integralconnector band 20 forms an arch 72 between the first tooth fitmentportion 116 and the second tooth fitment portion 216 which is receivedagainst a palatal surface of at least the incisors and canines of auser. In certain embodiments, the arch 72 may be substantially coplanarin a transverse plane defined at one or more points along the lingualbody edge 146 of the first tooth fitment portion 116 and the secondtooth fitment portion 216. In certain embodiments configured for use onthe lower teeth, the arch 72 may be positioned above a transverse planedefined at one or more points along the lingual body edge 146 of thefirst tooth fitment portion 116 and the second tooth fitment portion216. In embodiments configured for use on the upper teeth, the arch 72may be positioned below a transverse plane defined at one or more pointsalong the lingual body edge 146 of the first tooth fitment portion 116and the second tooth fitment portion 216.

The mesial body edge 140 of the first tooth fitment portion 116 may bepositioned at mesial of the first premolar and the distal body edge 142of the first tooth fitment portion 116 may be positioned at distal ofthe second molar to position the first tooth fitment portion 116 betweenat least the first premolar and second molar for exemplary purposes.Similarly, the mesial body edge 140 of the second tooth fitment portion216 may be positioned at mesial of the first premolar and the distalbody edge 142 of the second tooth fitment portion 216 may be positionedat distal of the second molar to position the second tooth fitmentportion 216 between at least the first premolar and second molar forexemplary purposes. The mesial edge 40 of the first spacer 32 may bepositioned over the mesio-occlusal surface of the second premolar andthe distal edge 42 of the first spacer 32 is positioned at about thedisto-occlusal surface of first molar on the left side of the mouth forexemplary purposes. The mesial edge 40 of the second spacer 34 ispositioned over the mesio-occlusal surface of the second premolar andthe distal edge of the second spacer 34 is positioned at about thedisto-occlusal surface of first molar on the right side of the mouth forexemplary purposes. FIG. 3C illustrates a rear view of an oral appliance10 with the integral connector band 20 and the channels 18 extendingthrough the first tooth fitment portion 116 and the second tooth fitmentportion 216.

FIGS. 4A and 4C illustrate various features of an embodiment of an oralappliance 10 for positioning on lower teeth of a user. As illustrated,one or more molars and premolars may be positioned within the channel 18defined by each of the first tooth fitment portion 116 and the secondtooth fitment portion 216. The integral connector band 20 is configuredto extend around the front of the mouth along the palatal surface ofincisors and canines. The integral connector band 20 defines a pluralityof recesses 22 shaped to receive a labial surface of the incisors andcanines of a user. The integral connector band 20 extends mesial fromlingual sides of the mesial body edges 140 of the first tooth fitmentportion 116 and the second tooth fitment portion 216. The integralconnector band 20 forms an arch 72 between the first tooth fitmentportion 116 and the second tooth fitment portion 216 which is receivedagainst a palatal surface of at least the incisors and canines of auser. In certain embodiments, the arch 72 may be substantially coplanarin a transverse plane defined at one or more points along the lingualbody edge 146 of the first tooth fitment portion 116 and the secondtooth fitment portion 216. In certain embodiments configured for use onthe lower teeth, the arch 72 may be positioned above a transverse planedefined at one or more points along the lingual body edge 146 of thefirst tooth fitment portion 116 and the second tooth fitment portion216. In embodiments configured for use on the upper teeth, the arch 72may be positioned below a transverse plane defined at one or more pointsalong the lingual body edge 146 of the first tooth fitment portion 116and the second tooth fitment portion 216.

The mesial body edge 140 of the first tooth fitment portion 116 may bepositioned at mesial of the first premolar and the distal body edge 142of the first tooth fitment portion 116 may be positioned at distal ofthe second molar to position the first tooth fitment portion 116 betweenat least the first premolar and second molar for exemplary purposes.Similarly, the mesial body edge 140 of the second tooth fitment portion216 may be positioned at mesial of the first premolar and the distalbody edge 142 of the second tooth fitment portion 216 may be positionedat distal of the second molar to position the second tooth fitmentportion 216 between at least the first premolar and second molar forexemplary purposes. The mesial edge 40 of the first spacer 32 may bepositioned over the mesio-occlusal surface of the second premolar andthe distal edge 42 of the first spacer 32 is positioned at about thedisto-occlusal surface of first molar on the left side of the mouth forexemplary purposes. The mesial edge 40 of the second spacer 34 ispositioned over the mesio-occlusal surface of the second premolar andthe distal edge of the second spacer 34 is positioned at about thedisto-occlusal surface of first molar on the right side of the mouth forexemplary purposes. FIG. 4C illustrates a rear view of an oral appliance10 with the integral connector band 20 and the channels 18 extendingthrough the first tooth fitment portion 116 and the second tooth fitmentportion 216.

FIG. 5A illustrates a side view of an exemplary embodiment of acomposite oral appliance positioned on the upper teeth of a user. Thecomposite oral appliance 10 is secured over the upper teeth of a userwith a channel 18 that extends over all of the upper teeth and definesrecesses 22 receiving a portion of the palatal of the incisors andcanines. The channel 18 extends from the disto-incisal of the canine tothe disto-occlusal of at least the second molar for exemplary purposes.The integral retention band 20 extends around the palatal side (lingualside if the composite oral apparatus 10 was fit for lower teeth) of theincisors, canines and first pre-molar for exemplary purposes.Particularly, the integral retention band 20 extends from the lingualsides of the mesial body edges 140 of the first tooth fitment portion116 and the second tooth fitment portion 216. As illustrated, the bitepad 12, 14 includes a spacer 32, 34 positioned within the tooth fitmentportion 116, 216. The illustrated spacers 32, 34 have a thicker rearedge that tapers to a thinner front edge for exemplary purposes.Further, the bite pads 32, 34 are formed as two separate components thatcooperate to form a wedge shaped bite pad 32, 34 for exemplary purposes.

FIG. 5B illustrates a cross section through section 3B-3B of thecomposite oral appliance of FIG. 5A illustrating the composite structureof each of the teeth fitment portions 116, 216. The channel 18 is shownextending downward from a buccal body edge 144 of the teeth fitmentportions 116, 216 and around to the lingual body edge 146. The innersurface of channel 18 as illustrated is shaped to correspond with theprofile of at least a portion of the teeth of a user. The inner shapemay at least in part be formed in the inner material 36 which in theillustrated embodiment forms the inner layer 26 of the compositestructure of the bite pad 32, 34 and/or teeth fitment portions 116, 216.The channel occlusal surface 24 is shaped to conform to the occlusalsurfaces of the adjacent teeth. More particularly, the portion of theinner material 36 which defines the channel occlusal surface 24 isshaped to receive the occlusal surface of a molar. Similarly, theexternal occlusal surface 22 is shaped to receive at least a portion ofthe occlusal surfaces of the adjacent teeth. Among other things, thisinternal shaping may improve one or more of comfort, retention andshock/force dispersion. The outer surface the buccal wall and lingualwall of the outer layer 28 may be shaped to correspond to the shape ofthe underlying teeth which may improve comfort and the aesthetics ofsome embodiments.

The inner material 36 of the inner layer 26 may be secured to the outermaterial 38 of the outer layer 28 along at least a portion of thelingual wall and at least a portion of the buccal wall and along otherportions of the teeth fitment portions 116, 216 where the inner material36 of the inner layer 26 and the outer material 38 of the outer layer 28come into contact. In various aspects, the materials 36, 38 of thelayers 26, 28 may be heat fused, chemically linked, adhesively bonded,mechanically interconnected or otherwise secured to one another as willbe recognized by those skilled in the art upon review of the presentdisclosure. At least a portion of the inner material 36 of the innerlayer 26 in the lower portion of the channel 18 is at least in partpositioned against and in some embodiments secured to spacer channelsurface 48 of the spacers 32, 34. At least a portion of the outer layer26 defining the channel occlusal surface 22 is positioned against and insome embodiments secured to a spacer outer surface 50 of the spacer 32,34. In various aspects, the materials 36, 38 of the layers 26, 28 may beheat fused, chemically linked, adhesively bonded, mechanicallyinterconnected or otherwise secured to the spacer surfaces 48, 50 aswill be recognized by those skilled in the art upon review of thepresent disclosure. The spacers 32, 34 may be encapsulated between orotherwise secured to or within the inner materials 36 of the inner layer26 and the outer material 38 of the outer layer 38 which form the teethfitment portions 116, 216 of the oral appliance 10. At least a portionof the mounting portion 62 of the integral retention band 20 is securedto or integral with one or more of the inner layer 26 and the outerlayer 28 of the teeth fitment portions 116, 216. In certain aspects, theintegral retention band 20 may be integrally formed with one or both ofthe inner layer 26 and the outer layer 28. In other aspects, theintegral retention band 20 may be secured at one or more ends to one orboth of the inner layer 26 and the outer layer 28 of the teeth fitmentportions 116, 216.

FIG. 5C to 5E illustrate an exploded perspective view of other exemplaryembodiments of the components of the oral appliance 10 and an exemplaryforming apparatus 100 as the components may be assembled duringmanufacture. As illustrated, the method includes configuring andassembling at least an outer blank 128, a pair of spacers 32, 34, and aninner blank 126 to form an oral appliance 10. The components may alsoinclude an inner material 36 and an integral retention band 20. For eachcomposite oral appliance 10, a model 30 of upper or lower teeth overwhich the oral appliance 10 will be formed is provided. The model 30 istypically formed by casting liquid stone or plaster in an impression ofthe upper or lower teeth of a user or into a standardized mold.Initially, the inner blank 126 is formed over the model 30 to assume theshape of the model 30 and, hence, the teeth of the user or standard onwhich the model 30 is based. The various components are positioned overthe formed inner blank 126 on the model 30 and the outer blank 128 ifformed over the model 30 and associated components to the interconnectedcomponents may then have the excess materials removed to produce acomposite oral appliance 10.

A pressure forming apparatus 100 may be provided. The pressure formingapparatus 100 is generally configured to exert a force over a surface ofthe outer blank 128 to form it over the model 30 and associatedcomponents of the oral appliance 10. As will be recognized by thoseskilled in the art, a wide range of pressure forming apparatus may beused to form the outer blank 128 over the model 30 and may be applicableto the present methods. By way of non-limiting examples, the pressureforming apparatus 100 may be one or more of various devices forproviding pneumatic pressure, hydraulic pressure, mechanical pressure ormay use other forces to form the outer blank 128 to over the model 30and associated components of the oral appliance 10.

In one step, the model 30 is placed in a forming chamber 102 of apressure forming apparatus 100. An inner blank 126 of the materialdesired to form the inner layer 26 is provided. When the material isEVA, the inner blank 126 may have a thickness from about 1.0 millimetersto about 6.0 millimeters and is typically between 0.8 millimeters toabout 4.0 millimeters in thickness. The inner blank 126 is secured inthe pressure forming apparatus 100 to sealingly separate the formingchamber 102 from a high pressure chamber 104 as generally illustrated inFIG. 5D. The temperature of the inner blank 126 and/or the formingchamber 102 and high pressure chamber 104 as well as the model 30 may beraised to soften the inner blank 126. A pressure gradient is thengenerated between the high pressure chamber 104 and the forming chamber102 to deform the inner blank 126 and force at least a portion of theinner blank 126 into the forming chamber 102 and against the model 30.As the inner blank 126 is forced against the model 30 in the formingchamber 102, a lower surface and, to varying degrees, an upper surface,of the inner blank 126 conforms to the shape of the model 30 asgenerally illustrated in FIG. 5E.

In another step, the inner material 36 may be positioned over theportion of the inner blank 126 onto which the spacers 32, 34 are to besecured. The inner material 36 may function to secure the spacers 32, 34at the desired location on the model 30 during manufacture. As such, theinner material 36 may be placed on the inner blank 126 over at least oneor more of the canines, premolars, and molars of the model 30 over atleast a portion of the area on which the spacers 32, 34 will be secured.The inner material 36 may at least in part be selected to stabilize theposition of the spacer 32, 34 on the inner blank 126 over the occlusalsurfaces of one or more of the molars and/or premolars of the model 30during manufacture.

The spacers 32, 34 are positioned at the desired location on an uppersurface of or otherwise positioned over of the inner blank 126 and/or,when present, the inner material 36. In certain aspects, the spacers 32,34 may be secured at the desired location on or in the inner material36. The spacer channel surface 48 of the spacers 32, 34 is positionedagainst the inner blank 126 and/or, when present, the inner material 36.

The molded inner blank 126 and associated components are then positionedin the forming chamber 102 under the outer blank 128. When the outermaterial 38 is an EVA for example, the outer blank 128 may have athickness from about 1.0 millimeters to about 6.0 millimeters andtypically has a thickness between about 1.8 millimeters to about 4.0millimeters. The outer blank 128 is secured in the pressure formingapparatus 100 to sealingly separate the forming chamber 102 from a highpressure chamber 104. The temperature of the outer blank 128 and/or theforming chamber 102 and high pressure chamber 104 as well as the model30 may be raised to soften the outer blank 128. A pressure gradient isthen generated between the high pressure chamber 104 and the formingchamber 102 to deform the outer blank 128 and force at least a portionof the outer blank 128 into the forming chamber 102 and against thespacers 32, 34, at least some of the inner material 36 and the model 30.Among other methodologies, the pressure gradient may be formed byincreasing the pressure in the high pressure chamber 102 or forming atleast a partial vacuum in the forming chamber 102. The temperatures andpressure differential may be selected to secure the outer blank 128 tothe inner blank 126 and/or, when present, the inner material 36 wherethey come into contact. Similarly, the temperatures and pressuredifferential may be selected to secure the outer blank 128 and/or theinner blank 126 and/or, when present, the inner material 36 to thespacer 32, 34 where they come into contact with the spacer 32, 34. Incertain embodiments, the temperature and pressure are configured to fusethe materials of at least two of the outer blank 128, the inner blank126 and the spacer 32, 34. As the outer blank 128 is forced against theinner blank 126 and in the forming chamber 102, a lower surface of theouter blank 128 conforms to the shape of the spacers 32, 34, the innerblank 126 and/or, to some degree, depending upon its formulation andstate, the inner material 36 when present. The integral retention band20 may be secured to the oral appliance 10 prior to or subsequent toplacement of the model 30 in the pressure forming apparatus 100. Inmethods where the integral retention band 20 is secured to the teethfitment portions 116, 216, one or more ends of the integral retentionband 20 may be secured to, in or between one or more of the outer blank128, the spacers 32, 34, the inner blank 126 and, when present, theinner material 36. In certain aspects, the integral retention band 20may be secured in a desired position relative to the model 30 such thatthe ends of the integral retention band 20 are or will be positionedwithin or on at least one of the inner sheet material 37 of the innerblank 126, the outer material 38 of the outer blank 128 or otherwisesecured at the desired position in each of the first teeth fitmentportion 116 and the second teeth fitment portion 216. As will be notedby those skilled in the art upon review of the present disclosure,various chemical treatments, adhesives, or other components may beintegrated into the components or positioned between the layers toimprove or alter the securing, bonding, connecting, linking and/orintegration of the various components of the oral appliance 10.

After the over-molding process, the oral appliance 10 is removed fromthe model 30 and may be trimmed of excess material. In methods where theintegral retention band 20 is integral with one or both of the firstteeth fitment portion 116 and the second teeth fitment portion 216, theintegral retention band 20 may be formed by cutting away and trimmingthe excess material of inner sheet 126 and outer sheet 128 from themodel leaving the desired configuration of integral retention band 20integrally connected to both the first teeth fitment portion 116 and thesecond teeth fitment portion 216. In certain aspects, on of either theinner sheet 126 or the outer sheet 128 may also be removed from at leasta portion of the integral retention band 20 to reduce the thickness ofthe integral retention band.

Further, the oral appliance 10 may be mounted on an articulator andheated to form an impression of the opposing teeth on the surfaceopposite the cavity 18. Alternatively, the oral appliance 10 may beheated and manually articulated to form an impression of the opposingteeth on the surface opposite the cavity 18.

FIG. 6A illustrates a side view of an exemplary embodiment of acomposite oral appliance positioned on the upper teeth of a user. Thecomposite oral appliance 10 is secured over the upper teeth of a userwith a channel 18 that extends in an arch around the mouth from themesio-occlusal of the third molar to the mesio-occlusal of the thirdmolar on the opposite side of the mouth. The channel occlusal surface 24is shown configured to conform to the shape of the occlusal surface ofthe upper teeth. As illustrated, the bite pad 12, 14 includes spacers32, 34 positioned within the first teeth fitment portion 116 and secondteeth fitment portion 216. The illustrated spacers 32, 34 have agenerally uniform thickness for exemplary purposes. Further, the bitepads 32, 34 are formed as a unitary component that is formed in arectangular shape for exemplary purposes. The integral retention band 20extends around both the labial and palatal sides of the incisors,canines and the pre-molar such that channel 18 is continuously formed inan arch 72 to receive at least all of the incisors and canines of theuser for exemplary purposes.

FIG. 6B illustrates a cross section through section 6B-6B of thecomposite oral appliance of FIG. 6A illustrating the composite structureof this portion of the oral appliance 10. The channel 18 is shownextending downward from a buccal body edge 144 of the body 116, 216 andaround to the lingual body edge 146. The inner surface of channel 18 asillustrated is shaped to correspond with the profile of at least aportion of the teeth of a user. The inner shape may at least in part beformed in the inner material 36 which in the illustrated embodimentforms the inner layer 26 of the composite structure of the bite pad 32,34 and/or teeth fitment portions 116, 216. The channel occlusal surface24 is shaped to conform to the occlusal surfaces of the adjacent teeth.More particularly, the portion of the inner material 36 which definesthe channel occlusal surface 24 is shaped to receive the occlusalsurface of a molar. Similarly, the external occlusal surface 22 isshaped to receive at least a portion of the occlusal surfaces of theadjacent teeth. Among other things, this internal shaping may improveone or more of comfort, retention and shock/force dispersion. The outersurface the buccal wall and lingual wall of the outer layer 28 may beshaped to correspond to the shape of the underlying teeth which mayimprove comfort and the aesthetics of some embodiments.

The inner material 36 of the inner layer 26 may be secured to the outermaterial 38 of the outer layer 28 along at least a portion of thelingual wall and at least a portion of the buccal wall and along otherportions of the body 116, 216 where the inner material 36 of the innerlayer 26 and the outer material 38 of the outer layer 28 come intocontact. In various aspects, the materials 36, 38 of the layers 26, 28may be heat fused, chemically linked, adhesively bonded, mechanicallyinterconnected or otherwise secured to one another as will be recognizedby those skilled in the art upon review of the present disclosure. Atleast a portion of the inner material 36 of the inner layer 26 in thelower portion of the channel 18 is at least in part positioned againstand in some embodiments secured to spacer channel surface 48 of thespacers 32, 34. At least a portion of the outer layer 26 defining thechannel occlusal surface 22 is positioned against and in someembodiments secured to a spacer outer surface 50 of the spacer 32, 34.In various aspects, the materials 36, 38 of the layers 26, 28 may beheat fused, chemically linked, adhesively bonded, mechanicallyinterconnected or otherwise secured to the spacer surfaces 48, 50 aswill be recognized by those skilled in the art upon review of thepresent disclosure. The spacers 32, 34 may be encapsulated between orotherwise secured to or within the inner materials 36 of the inner layer26 and the outer material 38 of the outer layer 38 which form the bodies116, 216 of the oral appliance 10. At least a portion of the integralretention band 20 may be secured between the inner layer 26 and theouter layer 28. Various other structures of the integral retention band20 may extend into, through and between one or more layers 26, 28 of thebodies 116, 216 and into and through the spacers 32, 34 to secure themajor connector relative to these elements.

FIG. 6C illustrates an exploded perspective view an exemplary embodimentof the components of the oral appliance 10 as the components may beassembled during manufacture. As illustrated, the method includesconfiguring and assembling at least an inner material 36, a pair ofspacers 32, 34 and an outer blank 128 to form a composite oral appliance10. The components may also include an integral retention band 20. Foreach oral appliance 10, a model 30 of upper or lower teeth over whichthe oral appliance 10 will be formed is provided. The model 30 istypically formed by casting liquid stone or plaster in an impression ofthe upper or lower teeth of a user or into a standardized mold. Thevarious components are positioned over the model 30 and the outer blank128 is formed over the model 30 and associated components to theinterconnected components may then have the excess materials removed toproduce a composite oral appliance 10.

In one step, the inner material 36 which will form the inner layer 26over at least a portion of the channel occlusal surface 24 of thechannel 18 is positioned on the model 30. Typically, the inner material36 is placed over at least one or more of the canines, premolars, andmolars of the model 30. The inner materials 36 will typically form atleast a portion of inner layer 24 on the channel occlusal surface 24 ofchannel 18. The material 36 may be temporarily secured to the model bysoftening it with heat, by press fitting it onto the model 30 orotherwise as will be recognized by those skilled in the art depending onthe material being used. The inner material 36 may be in a solid or aliquid form and may be a material such as one of various EVA basedadhesives, various uncured polymers, various heat softening polymers,various light curable polymers or other materials as will be recognizedby those skilled in the art upon review of the present disclosure. Theinner material 36 is positioned at a desired location on the model 30.Typically, the inner material 36 is positioned on at least a portion ofthe occlusal surfaces of one or more of the molars and premolars. Incertain embodiments, the inner material 36 is positioned on at least aportion of the occlusal surfaces at least the second premolar and thefirst molar of the model 30. The inner material 36 is generally selectedand/or prepared to be formable over the teeth of model 30 as the outerblank 128 is made to conform to the model 30. It is desirable that theinner material 36 may satisfy the comfort and durability requirementsfor an inner surface of an oral appliance 10 as will be recognized bythose skilled in the art upon review of the present disclosure. Theinner material 36 may at least in part be selected to stabilize theposition of the spacer 32, 34 on one or more of the molars and/orpremolars of the model during manufacture.

The spacers 32, 34 are positioned at the desired location on an uppersurface of or otherwise over the inner material 36. In certain aspects,the spacers 32, 34 may be secured at the desired location on or in theinner material 36. The spacer channel surface 48 of the spacers 32, 34is positioned against the inner material 36. The inner material 36 maybe made or may be provided as soft or tacky because of being achemically treated, uncured, heated or softened or may have otherproperties or configurations to enable the spacers 32, 34 to bepositioned relative to inner material 36 during manufacture as will berecognized by those skilled in the art upon review of the presentdisclosure. Prior to, during or after, the positioning of the spacers32, 34, the integral retention band 20 may be positioned on the model30. The integral retention band 20 may be positioned relative to thespacers 32, 34 and inner material 36 to facilitate their cooperation insecuring the integral retention band 20 if required by the particulardesign of the oral appliance 10. In certain designs, the integralretention band 20 may alternatively secured to the other components atafter the outer blank 128 is formed over the model 30 or after theexcess material from the forming step has been removed.

Similar to the illustrative exemplary embodiment of FIGS. 5D and 5E, themodel 30 is placed in a forming chamber 102 of a pressure formingapparatus 100 that uses pneumatic pressure to form the outer blank 128over the model. The outer blank 128 of the outer material 38 desired toform the outer layer 26 is provided. When the outer material 38 is anEVA for example, the outer blank 128 may have a thickness from about 1.0millimeters to about 6.0 millimeters and is typically between about 1.8millimeters to about 4.0 millimeters. When the outer material 38 is asheet of composite material including laminated an upper layer ofpolycarbonate and a lower layer of polyester urethane (the lower layerto be positioned against the teeth), the outer blank 128 may have athickness of between about 1.0 millimeter and 6.0 millimeters with atypical thickness dimension being 0.8 mm of polycarbonate material and1.0 millimeters of polyester urethane. The outer blank 128 is secured inthe pressure forming apparatus 100 to sealingly separate the formingchamber 102 from a high pressure chamber 104. The temperature of theouter blank 128 and/or the forming chamber 102 and high pressure chamber104 as well as the model 30 may be raised to soften the outer blank 128.A pressure gradient is then generated between the high pressure chamber104 and the forming chamber 102 to deform the outer blank 128 and forceat least a portion of the outer blank 128 into the forming chamber 102and against the spacer 38, at least some of the inner material 36 andthe model 30. Among other methodologies, the pressure gradient may beformed by increasing the pressure in the high pressure chamber 102 orforming at least a partial vacuum in the forming chamber 102. Thetemperatures and pressure differential may be selected to secure theouter blank 128 to the inner material 36 where they come into contact.Similarly, the temperatures and pressure differential may be selected tosecure the outer blank 128 and/or the inner material 36 to the spacer32, 34 where they come into contact with the spacer 32, 34. In certainembodiments, the temperature and pressure are configured to fuse thematerials of at least two of the outer blank 128, the inner material 36and the spacer 32, 34. As the outer blank 128 is forced against themodel 30 in the forming chamber 102, a lower surface of the outer blank128 conforms to the shape of the spacers 32, 34, the model 30, and, tosome degree, depending upon its formulation and state, the innermaterial 36. The integral retention band 20 may be secured to the oralappliance 10 prior to or subsequent to placement of the model 30 in thepressure forming apparatus 100. In methods where the integral retentionband 20 is secured at this step, the major connector may be secured inor between one or more of the outer blank 128, the spacers 32, 34 andthe inner material 36. In certain aspects, the integral retention band20 may be secured in a desired position relative to the model 30 suchthat the mounting portion 62 is or will be positioned within or on atleast one of the inner material 36 and material of the outer blank 128or otherwise secured at the desired position in each of the first teethfitment portion 116 and the second teeth fitment portion 216. As will benoted by those skilled in the art upon review of the present disclosure,various chemical treatments, adhesives, or other components may beintegrated into the components or positioned between the layers toimprove or alter the securing, bonding, connecting, linking and/orintegration of the various components of the oral appliance 10.

After the over-molding process, the oral appliance 10 is removed fromthe model 30 and may be trimmed of excess material. In methods where theintegral retention band 20 is integral with one or both of the firstteeth fitment portion 116 and the second teeth fitment portion 216, theintegral retention band 20 may be formed by cutting away and trimmingthe excess material of inner sheet 126 and outer sheet 128 from themodel leaving the desired configuration of integral retention band 20integrally connected to both the first teeth fitment portion 116 and thesecond teeth fitment portion 216. In certain aspects, on of either theinner sheet 126 or the outer sheet 128 may also be removed from at leasta portion of the integral retention band 20 to reduce the thickness ofthe integral retention band.

Further, the oral appliance 10 may be mounted on an articulator andheated to form an impression of the opposing teeth on the surfaceopposite the cavity 18. Alternatively, the oral appliance 10 may beheated and manually articulated to form an impression of the opposingteeth on the surface opposite the cavity 18.

The foregoing discussion discloses and describes merely exemplaryembodiments of the present invention. Upon review of the specification,one skilled in the art will readily recognize from such discussion, andfrom the accompanying drawings and claims, that various changes,modifications and variations can be made therein without departing fromthe spirit and scope of the invention as defined in the followingclaims.

What is claimed is:
 1. A composite oral appliance, comprising: a body defining at least a first teeth fitment portion and a second teeth fitment portion including an integral retention band securing the first teeth fitment portion to the second teeth fitment portion, each of the first teeth fitment portion and the second teeth fitment portion configured to be secured over at least some teeth of a user, each of the first teeth fitment portion and the second teeth fitment portion comprising a composite structure, the composite structure comprising at least an outer layer secured over an inner layer, the first teeth fitment portion further defining at least a first bite pad and the second teeth fitment portion defining at least a second bite pad, the composite structure at each of the first bite pad and the second bite pad comprising two or more spacers secured between an outer layer and an inner layer, the first bite pad and the second bite pad in positions to contact at least one of a molar and a premolar when worn by the user, an inner surface of the inner layer defining the shape of the teeth of a user; and wherein the two or more spacers increase in thickness from a first end to a second end to reduce pressure or transfer force during clenching of teeth.
 2. A composite mouthpiece comprising: a first bite pad and a second bite pad for opposite sides of the mouth, respectively, the first bite pad including a first fitment portion, the second bite pad including a second teeth fitment portion; an integral retention band securing the first teeth fitment portion to the second teeth fitment portion, the integral retention band being configured to extend as an arch around a lingual side, a palatal side, or both of at least front teeth of a user; each of the first and second teeth fitment portions being configured to be secured over the occlusal surfaces of at least one of the premolars and at least one of the molars or over the occlusal surfaces of one or more molars, being formed with a teeth engaging channel, and being of a composite structure comprising an inner layer, an outer layer and two or more spacers embedded or encapsulated between said layers, to maintain separation of the occlusal surfaces of the premolars and molars during stress-related clenching or upon impact on a jaw; the inner layer conforming to a model of one of an upper set of teeth and a lower set of teeth, the outer layer also conforming to the model so that outer surfaces of the buccal wall and of the lingual wall of the outer layer are shaped to conform to the teeth of the model, the retention band including recesses conforming to the front teeth of the model, and the outer and inner layers being secured together; wherein the two or more spacers increase in thickness from a first end to a second end to reduce pressure or transfer force during clenching of teeth.
 3. The mouthpiece of claim 2, wherein the teeth engaging channel is also defined in the retention band, which conforms to the lingual/palatal and buccal/labial sides of the teeth of the model and wraps around and covers the incisal edge of the teeth.
 4. The mouthpiece of claim 2, wherein the retention band extends along the palatal surface of the front teeth only and defines a plurality of recesses conforming to the palatal surface of the front teeth of the model.
 5. The mouthpiece of claim 2, wherein the retention band extends along the labial surface of the front teeth only and has a plurality of recesses conforming to the labial surface of the front teeth of the model.
 6. The mouthpiece of claim 5, wherein each tooth fitment portion includes a single spacer.
 7. The mouthpiece of claim 6, wherein the spacers are of a material of greater hardness than the material of the inner and outer layers.
 8. The mouthpiece of claim 7, wherein the spacers are of high density polyethylene or polypropylene.
 9. The mouthpiece of claim 8, wherein the first tooth fitment portion includes a first buccal body edge, and the second tooth fitment portion includes a second buccal body edge, and the first buccal body edge and the second buccal body edge extend below a lower gum-line of the user so that the mouthpiece fits over lower teeth of the user.
 10. The mouthpiece of claim 8, wherein the first tooth fitment portion includes a first buccal body edge, and the second tooth fitment portion includes a second buccal body edge, and the first buccal body edge and the second buccal body edge extend above an upper gum-line of the user so that the mouthpiece fits over upper teeth of the user.
 11. The mouthpiece of claim 2, wherein each tooth fitment portion includes a single spacer.
 12. The mouthpiece of claim 11, wherein each spacer is configured as a wedge.
 13. The mouthpiece of claim 2, wherein each spacer is formed as two separate components that cooperate to form a wedge.
 14. The mouthpiece of claim 2, wherein the spacers are of a material of greater hardness than the material of the inner and outer layer.
 15. The mouthpiece of 2, wherein the spacers are of high density polyethylene or polypropylene.
 16. The mouthpiece of claim 2, wherein the first tooth fitment portion includes a first buccal body edge, and the second tooth fitment portion includes a second buccal body edge, and the first buccal body edge and the second buccal body edge extend below a lower gum-line of the user so that the mouthpiece fits over lower teeth of the user.
 17. The mouthpiece of claim 2, wherein the first tooth fitment portion includes a first buccal body edge, and the second tooth fitment portion includes a second buccal body edge, and the first buccal body edge and the second buccal body edge extend above an upper gum-line of the user so that the mouthpiece fits over upper teeth of the user.
 18. The mouthpiece of claim 2, wherein the integral retention band is integral with the outer layer. 